Observational Study to Assess the Adequacy of Methadone Dosage, in Heroin Addicted Patients in a MMT.

Studio Osservazionale Per Valutare l'Adeguatezza Del Dosaggio Del Metadone, Nelle Terapie di Mantenimento, in Rapporto Agli Obbiettivi di Outcome, in Pazienti Tossicodipendenti da Eroina. (METODO)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02062736

Acronym

METODO

Enrollment

500

Registered

2014-02-14

Start date

2010-02-28

Completion date

2014-03-31

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Addiction

Keywords

methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone

Brief summary

The purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. The patients will be observed for two years.

Detailed description

500 patients will be selected among all patients addicted to heroin according to DSM-IV\_TR (Diagnostic and Statistical Manual of Mental Disorders IV\_ text revision), in maintenance methadone treatment, observed in the involved sites. The investigators will use treatment schemes with methadon conform to clinical practice and according to SPC (Summary of Product Characteristics). The enrollment will be competitive. Patients that meet incl/excl and that sign the informed consent, will be observed for 2 years. Follow up visits will be performed according to routine procedures, for patients that belong regularly to site at 3/6/9/12/18/24 months post V1. During the visits, patients will be assessed by validated and used as clinical practice questionnaires . For the evaluations of tolerability and safety the laboratory tests and electrocardiograms routinely performed will be collected.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Both sexes * Over 18 years of age * Patients with a diagnosis of heroin addiction according to ICD-10 (International Classification of Diseases) * Patients who have undertaken a methadone maintenance treatment * Adhesion to observational study by signing informed consent.

Exclusion criteria

* Inability to follow the observation * Diagnosis of decompensated psychotic disorders

Design outcomes

Primary

Measure	Time frame
the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage.	2 years ( 7 visits for patient )

Secondary

Measure	Time frame
QT prolongation risk in patients addicted to heroin who have undertaken MMT	2 years ( evaluation at t0, t0 +6/12/18/24 months)
psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages	2 years ( 7 visits for patient )
pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.	2 years ( 7 visits for patient )

Countries

Italy

Outcome results